NEW WARNING LABEL FOR FOSAMAX

As a result of ongoing investigations regarding Fosamax and use of bisphosphonates (BPs) to treat osteoporosis, the FDA has announced that the risk of atypical fractures of the thigh will be added to the Warnings and Precautions section of all labels of BP drugs.[1] Specifically, these atypical fractures are known as subtrochanteric and diaphyseal femur fractures. Recent studies strongly suggest there is a causal link between people who take BPs and the increased risk of these atypical fractures.[2] Furthermore, not only are people who take BPs put in greater risk of fracture, these particular types of fracture are especially more dangerous than more common femur fractures.[3] Additionally, the use of BPs results in longer and more complicated healing of the bone.[4]

What is a subtrochanteric and diaphyseal femur fracture?

Aytpical subtrochanteric femur fracture is a fracture occurring on the shaft of a femur immediately below the lesser trochanter. That is, right below the hip joint. These fractures are not common, rather they account for about only 7% to 10% of all “hip/femoral diaphyseal fractures.”[5]  Furthermore, given the unique nature of this fracture, special implants are required in order for the fracture to heal, and they are also more susceptible to malunion or nonunion. Additionally, those affected are liable to suffer long term effects. One study indicated that after 2 years, about 50% of persons who suffered a subtrochanteric fracture did not recuperate their pre-fracture walking abilities and faced difficulties performing routine activities.[6] A total of 71% could not live in the same conditions as they lived previously. [7]

A diaphyseal fracture on the other hand, is a fracture that occurs on the main or midsection of the femur. These of course are one of the more common fractures. What is significant however is that these fractures are more typically associated with high trauma incidents, whereas people taking BPs have incurred these fractures as a result of little to no trauma.[8]

In general there are also other features seen in people taking BPs that make these particular subtrochanteric and diaphyseal fractures atypical. First, the fractures are transverse, that is a straight break perpendicular to the shaft of the femur, or it is a straight angled break.  Second, the breaks are clean, in that the bones are not crushed or splintered as you would expect from high trauma breaks. Third, incomplete fractures tend to occur on the lateral side of the femur. Finally, more minor features include patients whose bones show evidence of an increase in the thickness of the femurs wall, delayed healing, and patients also report that weeks prior to the fracture they experienced symptoms such as dullness and aching in their groin or thigh. 

What’s the cause?

While it remains unclear whether BPs are the cause of the unusual femur fractures, the evidence has certainly convinced the FDA to prompt these new warning label requirements. What studies show is that BPs do increase bone density and strength, that is after all exactly what they prescribed to do. That increased strength and density however is achieve by reducing bone turnover. That means essentially instead of  the “out with the old, in with the new,” as is the case for normal bone “remodeling,” it is more like, “keeping the old, and piling on the new.” The problem however is that bones naturally incur cracks and micro damage, which is in turn naturally repaired by the body through the process of remodeling. Absent remodeling which is suppressed by the BPs, micro damage begins to accumulate. Over time, the end result is a thicker, much denser bone, albeit one that is less structurally sound, thus the increased risk in these atypical fractures.

In the short run, it may be that using BPs to combat osteoporosis is an effective treatment. However, for those patients unaware of the risks associated with BPs, like those who have been affected by Fosamax, evidence indicates that whether a person should undergo long term treatment requires a careful assessment of the risks versus its benefits. For this reason the FDA specifically recommends that health care professionals reevaluate a patients need to continue BP therapy, especially in those when have been treated with BPs over five years.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

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[1] US Food and Drug Admin. FDA Drug Safety Commc’n: Safety Update for Osteoporosis Drugs, Bisphosphonates, and Atypical Fractures (2010).

[2] Shane E, Burr D. Ebeling PR, et al. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research. 25 J. Bone Miner. Res. 2267 (2010).

[3] Id. at 2272.

[4] Id. at 2271.

[5] Id. at 2272.

[6] Id.

[7] Id.

[8] Id. at 2268.

U.S. SUPREME COURT AGAIN CURBS POWER OF CLASS ACTION LAWSUITS

Once again, the U.S. Supreme Court has curbed the powerful tool of class-action litigation in a ruling that will reverberate for decades, if not overturned. Earlier this week, the Supremes threw out the largest sex-discrimination lawsuit in U.S. history, siding with Wal-Mart against up to 1.6 million female workers in a decision that makes it harder to mount large-scale bias claims against the nation's other huge companies, too.

The lawsuit, citing what are now dated figures from 2001, argued that women are grossly underrepresented among managers, holding just 14 percent of store manager positions compared with more than 80 percent of lower-ranking supervisory jobs that are paid by the hour. Wal-Mart responded that women in its retail stores made up two-thirds of all employees and two-thirds of all managers in 2001.

By a 5-4 vote, the Court said the entire suit must be ended because the plaintiffs could not show that Wal-Mart had a common policy of discriminating against women. Instead, the company allowed individual store managers to decide on pay levels and promotions, the Justices found.

The majority agreed with Wal-Mart's argument that being forced to defend the treatment of female employees regardless of the jobs they hold or where they work is unfair. Scalia said there needed to be common elements tying together "literally millions of employment decisions at once." He said that in the lawsuit against the nation's largest private employer, "That is entirely absent here." Scalia's opinion strongly suggested that such claims cannot proceed as a single class-action suit unless the plaintiffs can point to a company policy of discriminating against certain classifications of employees.

In a statement, Wal-Mart said, "The court today unanimously rejected class certification and, as the majority made clear, the plaintiffs' claims were worlds away from showing a companywide discriminatory pay and promotion policy."

The decision will also most likely affect pending class-action claims against Costco and other large businesses. Corporations and companies as varied as the too-big-to-fail Wall Street firm Goldman-Sachs & Co., electronics giant Toshiba America Inc., and Cigna Healthcare Inc. also face class-action claims from women they employ. Had civil rights lawyers succeeded in the case, they had hoped to bring other suits against large employers who they claim relegate women or minorities to lower-paying jobs. This decision is as important to class action suits as the AT&T case decided earlier this month by the Supreme Court.

"This is an extremely important victory not just for Wal-Mart, but for all companies that do business in the
United States," a lawyer for the defendant said. The assessment was similar on the other side of the issue. Marcia D. Greenberger, co-president of the National Women's Law Center, said, "The court has told employers that they can rest easy, knowing that the bigger and more powerful they are, the less likely their employees will be able to join together to secure their rights." Wal-Mart potentially faced billions of dollars in damages if it had had to answer claims by the huge group of employees.

The employees who brought the case are left to pursue their claims on their own, with much less money at stake and less pressure on Wal-Mart to settle. Two of the named plaintiffs, Christine Kwapnoski and Betty Dukes, vowed to continue their fight, even as they expressed disappointment about the ruling.

"We still are determined to go forward to present our case in court. We believe we will prevail there," said Dukes, a greeter at a Wal-Mart in California. "All I have to say is when I go back to work tomorrow, I'm going to let them know we are still fighting," said Kwapnoski, an assistant manager at a Sam's Club in California. Their fight is all the more difficult under this ruling because they do not have the power of numbers on their side.

The women's lawyers said they were considering filing thousands of discrimination claims against Wal-Mart, but they acknowledged the court had dealt a fatal blow to their initial plan.

Justice Ruth Bader Ginsburg, writing for the court's four liberal justices, said there was more than enough to unite the claims. "Wal-Mart's delegation of discretion over pay and promotions is a policy uniform throughout all stores," Ginsburg said. Justices Elena Kagan, Sonia Sotomayor and Justice Stephen Breyer joined her opinion. Greenberger went on to opine, "The women of Wal-Mart, together with women everywhere, will now face a far steeper road to challenge and correct pay and other forms of discrimination in the workplace."

Big Business, including nearly two dozen large companies, lined up with Wal-Mart, while civil rights, women's and consumer groups sided with the women plaintiffs. Both sides accurately painted the case as extremely consequential. The business community said that a ruling for the women would lead to a flood of class-action lawsuits based on vague evidence. Supporters of the women suggested a decision in favor of Wal-Mart could remove a valuable weapon for fighting all variations of discrimination.

Latest Removal Procedure Ruling in Alabama

Earlier this month, Alabama Chief District Judge Watkins issued an opinion dealing with removal procedure in Stewart v. Bureaus Investment Group #1, 2011 WL 2313213.

In the Circuit Court of Macon County, Alabama, Bureaus brought a debt-collection action against Stewart.  Stewart answered and filed a counterclaim complaint, asserting a claim under the Fair Debt Collection Practices Act (FDCPA) and various state-law-based claims.  Bureaus dismissed its debt-collection complaint, leaving pending only Stewart’s counterclaims. 

Interestingly, Bureaus then moved to realign the parties and the state court granted its motion.  Thereafter, Bureaus filed a notice of removal, asserting federal-question jurisdiction, predicated on the FDCPA claim.  Stewart filed a motion to remand and argued that there was no removal jurisdiction because only defendants may remove and, when the matter was commenced Bureaus was the plaintiff.

As noted by Chief Judge Watkins, no Circuit Court of Appeals has addressed “whether an order of realignment by a state court can allow a former plaintiff, now defendant, to remove a case to federal court based upon a pleading that was originally filed as a counter-complaint.”  Chief Judge Watkins determined that such a former plaintiff/now defendant could and subsequently denied Stewart’s motion to remand.  Because removal jurisdiction is determined based on the situation at the time of removal, for Chief Judge Watkins, at the time of removal, Stewart was the plaintiff prosecuting claims against Bureaus, the defendant.  The prior procedural history was immaterial in the analysis.

Likely, Stewart did not oppose the motion for realignment because she believed that there was no possibility of removal because Bureaus had instituted the litigation as the plaintiff.  The lesson to be drawn is that, if confronted with this scenario, one should oppose a motion to realign because the motion is being filed solely to divest the state court of jurisdiction and unnecessary for any other purpose.  Chief Judge Watkins’s analysis may be correct but it would be interesting to see if the Eleventh Circuit would affirm if there is ever any appellate review. Obviously, this case could turn out significantly different in another venue.

Our firm handles many cases dealing with the above issues. Most of the cases we handle involve victims of identity theft who have their credit wrecked by the credit companies, collection agencies and the credit reporting agencies who do not practice due diligence when handling someone’s credit rating and score. Credit score has become one of the single most important tools used in the financial world today. Deciding whether to file in state or federal court is a major decision when handling these types of cases. If you have been a victim of identity theft and your credit rating has been negatively affected, contact me today for a free case evaluation.

ALABAMA SUPREME COURT SHORTENS STATUTE OF LIMITATIONS FOR WANTONNESS CLAIMS

In a move that is more symbolic than practical, the Alabama Supreme Court issued an opinion earlier this month effectively holding that the statute of limitations for a wantonness claim is two years and not six years. The case, Ex parte Capstone Building Corporation, No. 10900966, overruled the holding in McKenzie v. Killian, 887 So. 2d 861 (Ala. 2004). The Court found that McKenzie was wrongly decided and that there should be a return to the historical position of the two-year period. Chief Justice Cobb was the lone dissentor.

The Court’s ruling will be prospective only and will apply to any existing claims that would expire more than two years from the date of the decision. The Court ruled that, “litigants whose causes of action have accrued on or before [June 3, 2011] shall have two years from today’s date [June 3, 2011] to bring their action unless and to the extent that the time for filing their action under the six-year limitations period announced in McKenzie would expire sooner.” For example, if someone was injured in Alabama on June 3, 2006, they would only have until June 3, 2012, and not June 3, 2013, to file a claim.

The change has little practical effect because almost all wantonness claims are paired with negligence claims. The statute of limitations for a negligence claim in Alabama is currently two years.

DePuy Pinnacle MDL News

Our firm has four of the first Pinnacle cases filed in the DePuy Pinnacle MDL and anticipates filing more in the coming months. We are seeing rapid failures of the device due to high cobalt levels in blood tests. Excessive levels of cobalt in the blood stream is a sign of metallosis, which can cause rashes, soft-tissue damage, peripheral neuropathy and pseudo-tumors.

The DePuy Pinnacle cases have been consolidated in the U.S. District Court for the Northern District of Texas under Judge James E. Kinkeade. Judge Kinkeade is currently presiding over at least one of the cases, and the Panel determined his current caseload will accommodate the litigation. There are approximately 57 DePuy Pinnacle hip lawsuits currently pending in federal courts nationwide and that number is expected to rise over the next few months. 

DePuy is a subsidiary of Johnson & Johnson, one of the largest corporations in the world. DePuy recalled the ASR XL Acetabular hip system last August, after researchers found 13 percent of patients needed a repeat operation to fix problems with the implant. The company took a $280 million charge in the fourth quarter to pay for the recall. The company faces more than 500 lawsuits by patients who had the hip implants, most of which are consolidated in a separate MDL dealing only with ASR hips. There has been no recall of the DePuy Pinnacle hip.

Johnson & Johnson’s DePuy Orthopaedics division, a maker of artificial prosthetics such as hips and knees, has struggled with product recalls and lawsuits over faulty implants lately. It was announced earlier this year that the worldwide president would leave the company in March. The executive, David Floyd, has been president of the unit since 2007. He is leaving to pursue interests outside the company, a spokesman on behalf of the company, Lorie Gawreluk, said, declining to be more specific.

Our firm is currently investigating claims for those people who have been implanted with the DePuy hip replacement devices, both ASR and Pinnacles. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.